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The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The CAPILLARYS, CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively .

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

For In Vitro Diagnostic Use.

The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods:

• Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments and on SEBIA MINICAP instrument.
• Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, . HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.

The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control.

For In Vitro Diagnostic Use.

This submission includes:

• 1. CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 instrument (PN 1222) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions.
• 2. IT / IF Control (PN 4788) with the new device CAPILLARYS 2 instrument (PN 1222). The IT / IF Control was cleared in prior 510K submissions.
• 3. CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 FLEX PIERCING instrument (PN 1227) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions

The configurations of the CAPILLARYS IMMUNOTYPING kits consist of the components summarized in Tables I and II. Additional details are provided in Package Inserts included in Section III of the submission. Each kit with instrument is supplied with Package Insert/manual which contains instruction for use and all the necessary information on the components needed to run the test that are sold separately. Each Package insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately.

The provided document describes a 510(k) premarket notification for "CAPILLARYS IMMUNOTYPING" and "IT / IF CONTROL" systems. It focuses on demonstrating the substantial equivalence of these systems when used with the CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for device performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. The reported device performance is presented in terms of this equivalence across various aspects.

2. Sample Size Used for the Test Set and Data Provenance

The document provides limited specific details on the sample sizes used for the comparative studies.

• "CAPILLARYS IMMUNOTYPING KIT" (reagents): The reagents were previously cleared in K042939 (serum) and K082085 (urine). These prior submissions would contain the detailed sample sizes for the reagent validation. The current submission re-uses these validated reagents with new instruments.
• "IT / IF Control": The control was previously cleared in K101863. Like the reagents, the specific sample sizes for its validation with its original predicate would be in that prior submission. The current submission compares its performance on the CAPILLARYS 2.

The document states that "performance and comparative studies... were performed using Sebia's commercially available materials and standard procedures." It does not specify the country of origin of the data or explicitly state whether the studies were retrospective or prospective, though the nature of comparative studies for substantial equivalence often involves prospective testing with clinical samples or characterized controls.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for the test sets. The "electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins," which implies a visual interpretation by trained personnel. Given that these are IVD devices, it is implied that laboratory professionals/medical technologists would be involved in interpretation, but specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The evaluation is described simply as "evaluated visually," suggesting a direct interpretation rather than a multi-reader adjudication process as seen in some imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is an automated electrophoresis system for immunotyping, where the output (electrophoregrams) is visually interpreted. The focus is on the performance of the integrated system (reagent + instrument) compared to existing methods, rather than assessing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

The device is an automated electrophoretic system that separates and detects proteins. The "electrophoregrams are evaluated visually." This implies that the device provides the raw data, and human interpretation is still part of the diagnostic process. Therefore, a standalone (algorithm only) performance is not directly applicable in the context of this description, as it's not a fully automated diagnostic algorithm without human interaction. The device performs "all procedural sequences automatically to obtain a protein profile for qualitative analysis," but the final "evaluation" is still visual.

7. Type of Ground Truth Used

The ground truth is not explicitly stated as pathology, outcomes data, or expert consensus in this summary. However, given the nature of immunotyping, the ground truth for "detection and characterization of monoclonal proteins" would typically be established by established laboratory methods, often including confirmation by other techniques or clinical correlation. The comparison to predicate devices (Sebia HYDRAGEL IF kit, Paragon CZE 2000 IFE/s Control) implies that the ground truth for the samples used in the study was established by these well-accepted, previously cleared methods.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. This submission focuses on demonstrating substantial equivalence of the device and its components to existing, cleared devices. It's likely that any "training" or development data for the underlying technology (e.g., the reagents, instrument algorithms) would have occurred prior to the predicate device clearances (K042939, K082085, K101863) or during the development of the instruments themselves (K112550, K122101 for other assays). This 510(k) is about demonstrating the new combination's equivalence.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly discussed in the context of this 510(k) summary, how its ground truth was established is not detailed.

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